Crooked Trial Site Case: Federal Judge Sends Co-Investigator & Clinical Coordinator to Prison

Crooked Trial Site Case: Federal Judge Sends Co-Investigator & Clinical Coordinator to Prison

Clinical trial sponsors and contract research organizations (CROs): do your homework, ensure that you are working with noble, ethical, moral, and most definitely legally compliant players. Don’t just fall for the message that “lots of patients can be enrolled at our site, for your trial—and fast.” Yet another set of trial site operatives in Florida have been taken down and now are off to jail as a federal judge just sentenced a Florida nurse practitioner and co-principal investigator and a Florida clinical research coordinator to prison today in connection with their participation in a conspiracy to falsify clinical trials data—an egregious offense that can destroy a clinical program, create hundreds of millions in losses, and impose grave risk on patients. Thanks to an investigation that involved the Department of Justice (DOJ), the U.S. Attorney’s Office for the Southern District of Florida, the U.S. Food and Drug Administration (FDA), and a federal judge, a couple more bad actors from a crooked trial site organization will now pay their dues. Before summarizing the offense and penalties, TrialSite provides some perspective on perhaps some of the influencing factors that in some...

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